IRT Vendor Start-up Manager – UK or Ireland

🕒 vor 1 Monat

🌐 Vereinigtes Königreich, Irland – Remote

🇬🇧 Vereinigtes Königreich – Remote 🇮🇪 Irland – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

🇬🇧 UK-Skilled-Worker-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit UK-Skilled-Worker-Visa gesponsert.

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Parexel

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1983

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

💰 Venture Round im 1990-01

Consulting • Healthcare • Logistics

Parexel gehört zu den weltweit größten Auftragsforschungsinstituten (CROs) und bietet umfassende Services für den gesamten klinischen Entwicklungsprozess von Phase I bis IV. Das Unternehmen ist spezialisiert auf Portfolio-Management, Studienmanagement, Regulatory-Strategie, Market Access und Lifecycle-Management für Biopharmazeutika. Ziel von Parexel ist es, lebensverändernde Arzneimittel mithilfe seiner klinischen, regulatorischen und therapeutischen Expertise schneller auf den Markt zu bringen. Mit einem globalen Team von über 21. 000 Fachkräften integriert Parexel Patientenperspektiven und innovative Studiendesigns, um Therapien in Indikationsgebieten wie Onkologie, Neurowissenschaften, seltene Erkrankungen und mehr zu entwickeln. Im Fokus stehen patientenzentrierte und effiziente klinische Studien.

Beschreibung

• The Vendor Start-up Manager (VSM) will provide technical expertise for the category throughout start-up to close out to the VCE (Vendor Category Expert) and indirectly to the Clinical Trial Team. • The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization and ensures compliance through the life of the studies assigned. • This role proactively assesses risk and concludes contingency plans to de-risk study start-up and beyond. • Reviewing of the IRT vendor and category related specific sections of the protocol, ensuring IRT vendor expertise is leveraged when refining specifications towards Final Protocol. • Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of IRT Vendors. • Quote/Proposal review in collaboration with procurement (and vendor). • If required, support contract negotiations. • Vendor budget review of final quotes. • Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out. • Ensures all submission documents are provided by vendor, as required, to countries participating in a study. • Supports amendment of vendor contracts with Procurement team. • Optimizing a frontloaded and timely study start-up process in support of a timely site readiness. • IRT Vendor service excellence at study level, ensuring vendors meet quality and service level standards in their service delivery for the trial. • Acts as escalation point for vendor-related query management. • Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation. • Follow-up with countries and Hubs for their vendor-related risks and issues. • Document issues identified with vendor oversight/performance in sponsor’s internal tool and implements and monitors corrective actions. • Drive root cause analysis of supplier performance issues and look for trending.

🎯 Anforderungen

• 3+ years working experience and excellent knowledge of the clinical operation processes and IRT vendor management • Excellent knowledge of GxP and ICH regulations • Expert knowledge of clinical trial design and mapping to supplier requirements • Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas • Demonstrated partnering across divisions with internal and external stakeholders • Demonstrated root cause analysis, problem solving, and solution generation skills • Experience in IRT User Acceptance testing • Knowledge of key deliverables that impact green light milestones and vendor readiness • Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs • Bachelor's degree in science or business required, with equivalent experience.

🏖️ Vorteile

• Health insurance • Flexible work arrangements • Professional development opportunities